MAUDE Adverse Event Report: HL CORP DRIVE; KNEE WALKER

Model Number	790
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a knee walker.We have not received the device for evaluation.The end-user was utilizing the device throughout his recuperation from achilles tendon surgery.He was walking in the park aided by the knee walker when the right hand brake snapped.He fell to the pavement and reinjured his achilles tendon on his left side.

• Brand Name: DRIVE
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): HL CORP; the 3rd industrial park; bitou village, song gang town; baoan district, shenzhen, guangdong 51810 5; CH 518105
• MDR Report Key: 9603850
• Report Number: 2438477-2020-00003
• Device Sequence Number: 2677842
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2020
• Report Date (Section F): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2019
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/17/2020